CDER Office of Compliance director Jill Furman highlights a year of sweeping operational shifts, heightened enforcement, and emerging use of artificia...
FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young people following Co...
Former FDA associate commissioner Peter Pitts says CDER director Richard Pazdurs decision to abruptly retire was motivated by growing political interf...
Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy, achieved statist...
The CDER Accelerating Rare Disease Cures program Year-Three report shows a decline in new drug approvals and several other activities when compared wi...
The American Hospital Association suggests ways for FDA to develop a regulatory framework for measuring and evaluating AI-enabled medical devices.
A new Bloomberg report finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential expanded approval of...
FDA awards Eli Lilly traditional approval for Jaypirca (pirtobrutinib) and its use in adults with relapsed or refractory chronic lymphocytic leukemia ...
